Home NDC 67933-0321 PerCara Oral Health Rinse
Product NDC 67933-0321
11-digit product format 679330321
Labeler code 67933
Product ID 67933-0321_0eb38ee3-e0ad-58f5-e063-6294a90a8d5a
Type HUMAN OTC DRUG
Nonproprietary name Cetylpyridinium Chloride
Dosage form RINSE
Route ORAL
Labeler LEC Custom Products, Inc
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-15
Substance CETYLPYRIDINIUM CHLORIDE
Active strength .07 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warning Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help.
Additional Listing Data#
Finished product Yes
Brand name base PerCara Oral Health Rinse
Brand name suffix Fresh Mint
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETYLPYRIDINIUM CHLORIDE .07 g/100mL
Harmonized Identifiers# Field, Values table Field Values Unii D9OM4SK49P Rxcui 1100924
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67933-0321-1 PerCara Oral Health RinseFresh Mint 500 mL in 1 BOTTLE, PLASTIC RINSE 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67933-0321 PERCARA ORAL HEALTH RINSE FRESH MINT (CETYLPYRIDINIUM CHLORIDE) RINSE [LEC CUSTOM PRODUCTS, INC] 2 Current NDC, Legacy NDC, 1 package rows 20240116_bd98c654-218b-15ac-e053-2a95a90a75d1.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67933-0321-1 67933032101 500 mL in 1 BOTTLE, PLASTIC (67933-0321-1) 500 ml 2021-03-15 0000-00-00 No No Current